Jade GxP Validation with Enterprise IPaaS

Last updated Thu Sep 29 2022

Overview:

When enterprise data platforms like Boomi iPaaS are deployed in pharma and other healthcare industries, their operations involving good manufacturing processes, data records and digital signatures need to be controlled and validated in compliance with GxP guidelines such as 21 CFR Part 210, 211, and 11. 

GxP guidelines require organizations to provide documented, electronic evidence on the assurance and validation procedures carried out on their various systems for their respective domains. This documentation must be shared with regulatory bodies, such as the Food and Drug Administration (FDA) in the United States, on a regular basis. Similar regimes exist for other geographies.

To help companies ensure their compliance with GxP guidelines, Jade offers a three-phase engagement comprising the following steps:

Advisory Phase

  • Perform gap analysis against established regulatory guidelines and industry best practices
  • Develop Business case, Key Performance Indicators (KPIs) and actionable roadmap to achieve the to-be state
  • Develop policies and procedures, evaluate technology and vendors, perform and manage audits and Corrective and Preventive Action (CAPA)

Validation Phase

  • Perform vendor audit and system risk assessment
  • Develop validation plan
  • Develop user requirements and functional risk assessment
  • Develop functional and technical design specifications
  • Develop IQ, OQ, and PQ protocol, scripts, and reports
  • Develop traceability matrix and validation summary report
  • Develop training materials and train users
  • Develop procedures and work instructions

Infrastructure and Operational Qualification Testing Phase

  • Perform vendor audit and infrastructure risk assessment
  • Develop infrastructure qualification plan
  • Develop infrastructure requirements and specifications
  • Develop procedures, work instructions, and training materials
  • Author test protocol, scripts, and reports
  • Qualify infrastructure and establish change control framework
  • Develop infrastructure retirement and revalidation procedures
  • Develop audit trail procedures

Jade offers these advantages for its services:

  • A structured methodology and governance framework 
  • A blend of GxP compliance and expertise within life sciences domain as well as general technical expertise 
  • Templates and test accelerators developed based on several successful engagements

This solution requires Boomi Integration, B2B/EDI, Master Data Hub, and Flow.

As a Boomi Certified Elite Partner, Jade specializes in enterprise-grade solutions for all integration needs. Jade has successfully helped more than 150 high-tech businesses help their customers embrace challenges and become leaders in driving digital change.

Sample Use Case
Reference Architecture
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